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Completed

NCT Number: NCT04487301

A Cross-Sectional Study to Assess Walking Performance in Subjects With Peripheral Artery and End Stage Kidney Disease

A cross-sectional, non-interventional study to assess walking performance, vascular function, and lower limb calcification in subjects with peripheral artery disease and end-stage kidney disease (PAD-ESKD) receiving hemodialysis.

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Key information

Conditions

Peripheral Artery Disease Arterial Occlusive Diseases Arteriosclerosis Atherosclerosis Cardiovascular Diseases Chronic Disease Disease Attributes End Stage Renal Disease on Dialysis Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Kidney Failure, Chronic Male Urogenital Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Peripheral Arterial Disease Peripheral Vascular Diseases Renal Insufficiency Renal Insufficiency, Chronic Urogenital Diseases Urologic Diseases Vascular Diseases

Age range

45 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Valley Renal Medical Group, Northridge, California, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • ≥55 years of age or ≥45 years of age with diabetes
  • Receiving maintenance HD in a clinical setting for at least 2 weeks prior to screening
  • Resting ABI <0.90 in either leg OR Resting TBI <0.70 in either leg
  • Symptomatic as characterized by a limitation in exercise performance

Exclusion criteria

  • Above-ankle amputation
  • Chronic limb-threatening ischemia (Rutherford 4-6)
  • Non-ambulatory status
  • A condition other than PAD that limits ability to walk
  • Open or endovascular revascularization within 3 months prior to baseline.
  • Illnesses, conditions, or planned surgeries within the study period that will interfere with the interpretation of the study results

Treatment and study plan

Primary outcomes

  1. Six Minute Walk Test

    Time frame: Two six minute walk tests will be conducted separated by 5-7 days during Week 1 during the subject's participation of up to 4 weeks.

    Walking distance in meters completed over a duration of 6 minutes

  2. Activity Patterns

    Time frame: Functional activity measurements will be collected daily beginning at the completion of screening and daily for the duration of the subject's participation of up to 4 weeks.

    Actigraphy measurements as 24 hour intervals of motion using an accelerometer device

  3. Ankle Brachial Index

    Time frame: Will be conducted once in a vascular laboratory during the screening visit or visits during the subject's participation of up to 4 weeks

    Compares blood pressure in upper extremities and lower extremities

  4. Toe Brachial Index

    Time frame: Will be conducted once in a vascular laboratory during the screening visit or visits during the subject's participation of up to 4 weeks

    Compares blood pressure in upper extremities and lower extremities

  5. San Diego Claudication Questionnaire

    Time frame: Administered once during Day 1 of the screening visit during subject's participation of up to 4 weeks.

    Will categorize the subject's perception of the leg symptoms associated with PAD

  6. Walking Impairment Questionnaire

    Time frame: Administered once during Week 1 during subject's participation of up to 4 weeks.

    Will evaluate the subjects personal perception of walking ability.

  7. PAD Quality of Life

    Time frame: Administered once during Week 1 during subject's participation of up to 4 weeks.

    Will evaluate information about the subject's perception of social relationships, self-concepts and feelings, symptoms and limitations in physical functioning, fear and uncertainly, and positive adaptation.

  8. EQ-SD-SL Health Questionnaire

    Time frame: Administered once during Week 1 during subject's participation of up to 4 weeks

    Will evaluate the subject's perception of overall health status, mobility, self-care, usual activities, pain or discomfort, and anxiety or depression.

  9. Pulse Wave Velocity - Sub-Study

    Time frame: Will be conducted once in a vascular lab for subjects participating the in the sub-study during Week 3 of the subjects participation of 4 weeks.

    Measures arterial stiffness

  10. Flow-Mediated Dilation - Sub-Study

    Time frame: Will be conducted once in a vascular lab for subjects participating the in sub-study during Week 3 of the subjects participation of 4 weeks.

    Measures the ability of blood vessels to dilate

  11. Nitroglycerin-Medicated Dilation - Sub-Study

    Time frame: Will be conducted once in a vascular lab for subjects participating the in sub-study during Week 3 of the subjects participation of 4 weeks.

    Measures the ability of blood vessels to dilate after administration of nitroglycerin

  12. Lower limb calcification measurements

    Time frame: Will be conducted once in subjects participating the in sub-study during Week 3 of the subjects participation of up to 4 weeks.

    A non-contrast computed tomography scan of the lower extremities will be evaluated for arterial calcification.

Sponsors and collaborators

Lead sponsor

Sanifit Therapeutics S. A.

Other

Registry information

Official study title

A Cross-Sectional Non-Interventional Study to Assess Walking Performance, Quality of Life, Vascular Function, and Lower Limb Arterial Calcification in Subjects With Peripheral Artery Disease and ESKD Receiving Hemodialysis

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Jul 27, 2020
Registry last updated
Oct 14, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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